Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.

A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Health counselling by nurse navigator; Behavioral: Usual primary care counselling

Detailed Description

Primary Outcome Measure:

Number of patients who receive a letter and patient navigation services and get screened compared to the control group.

Secondary Outcome Measures:

Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.

Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.

• Study Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sault Ste. Marie, Ontario, Canada
      • Group Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Average risk men and women aged 50 - 74
• Unscreened - Defined as no prior CRC screening
• Under-screened - Defined as no FOBT screening within the last two years
• No colonoscopy or barium enema screening within the last five years
• Willing to provide consent to participate in the study.

Exclusion Criteria:

• FOBT within the last two years
• colonoscopy within five years
• barium enema within five years
• flexible sigmoidoscopy within five years
• Bowel cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navigator intervention	Behavioral: Health counselling by nurse navigator; Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral; Other Names: Nurse navigator assistance
Active Comparator: Usual Care Control; Usual care	Behavioral: Usual primary care counselling; Usual care health counselling on colorectal cancer and screening options; Other Names: Usual primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks	Completion of verified CRC screening events in experimental vs. control patients	48 weeks after baseline assessment

Secondary Outcome Measures

Outcome Measure	Time Frame
Screening preferences; predictors of CRC screening and screening preference.	48 weeks

Collaborators and Investigators

• Sponsor: Cancer Care Ontario
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Paul Ritvo, PHD, Cancer Care Ontario

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Colorectal cancer screening; 50 years or older
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 10-163